What we do
What we do
What we do
Generating the highest quality evidence with the least overhead and burden
Services
Services
Services
How we can help you
We provide three primary services relating to two areas: Analysis of COA data and COA Regulatory Strategy/Support. Analysis of COA data can be decomposed into pre-approval and post-approval activities.
Psychometric validation of COA Instruments and Scores
We support pre-approval COA programs through psychometric validation of new or legacy COA instruments. Our team has extensive hands-on experience conducting psychometric analysis (both modern and classical methods) and reporting of evidence.
Psychometric validation of COA Instruments and Scores
We support pre-approval COA programs through psychometric validation of new or legacy COA instruments. Our team has extensive hands-on experience conducting psychometric analysis (both modern and classical methods) and reporting of evidence.
Psychometric validation of COA Instruments and Scores
We support pre-approval COA programs through psychometric validation of new or legacy COA instruments. Our team has extensive hands-on experience conducting psychometric analysis (both modern and classical methods) and reporting of evidence.
Analysis and Interpretation of COA data
We support post-approval COA differentiation strategies with innovative statistical methods implemented to illuminate the strength of your COA data.
Analysis and Interpretation of COA data
We support post-approval COA differentiation strategies with innovative statistical methods implemented to illuminate the strength of your COA data.
Analysis and Interpretation of COA data
We support post-approval COA differentiation strategies with innovative statistical methods implemented to illuminate the strength of your COA data.
Regulatory COA Strategy Consulting & Support
Our COA Regulatory Strategy/Support is informed by our long experience in this field and a close understanding of existing regulatory guidance (draft or final), as well as historical and current trends emerging in ongoing regulatory interactions.
Regulatory COA Strategy Consulting & Support
Our COA Regulatory Strategy/Support is informed by our long experience in this field and a close understanding of existing regulatory guidance (draft or final), as well as historical and current trends emerging in ongoing regulatory interactions.
Regulatory COA Strategy Consulting & Support
Our COA Regulatory Strategy/Support is informed by our long experience in this field and a close understanding of existing regulatory guidance (draft or final), as well as historical and current trends emerging in ongoing regulatory interactions.
Services
Services
Services
How we can help you
This is what we do best.
How we do what we do
COA Instrument Selection
We help sponsor’s to identify and select appropriate COA instruments that measure key signs, symptoms, and impacts within the context of use. To support COA Instrument selection and strategy development, we offer:
Extensive targeted literature reviews
COA gap analysis
Landscape assessments (competitor and/or disease)
COA Instrument Selection
We help sponsor’s to identify and select appropriate COA instruments that measure key signs, symptoms, and impacts within the context of use. To support COA Instrument selection and strategy development, we offer:
Extensive targeted literature reviews
COA gap analysis
Landscape assessments (competitor and/or disease)
COA Instrument Selection
We help sponsor’s to identify and select appropriate COA instruments that measure key signs, symptoms, and impacts within the context of use. To support COA Instrument selection and strategy development, we offer:
Extensive targeted literature reviews
COA gap analysis
Landscape assessments (competitor and/or disease)
Psychometric Validation of COA instrument(s)
We pride ourselves on having specialist training and hands- on experience specific to our service oferings and on our ability to contribute to all aspects of our research projects, no matter the job title.
Evaluate structural validity and scoring algorithms
Examine reliability, validity, and ability to detect change
Estimate thresholds of meaningful change
Psychometric Validation of COA instrument(s)
We pride ourselves on having specialist training and hands- on experience specific to our service oferings and on our ability to contribute to all aspects of our research projects, no matter the job title.
Evaluate structural validity and scoring algorithms
Examine reliability, validity, and ability to detect change
Estimate thresholds of meaningful change
Psychometric Validation of COA instrument(s)
We pride ourselves on having specialist training and hands- on experience specific to our service oferings and on our ability to contribute to all aspects of our research projects, no matter the job title.
Evaluate structural validity and scoring algorithms
Examine reliability, validity, and ability to detect change
Estimate thresholds of meaningful change
COA data analysis
We have extensive experience with conducting statistical analysis of COA data for post-approval diferentiation in eficacy and safety We have expertise leveraging methods such as:
Linear and generalized linear mixed models
Survival models
Joint survival models
COA data analysis
We have extensive experience with conducting statistical analysis of COA data for post-approval diferentiation in eficacy and safety We have expertise leveraging methods such as:
Linear and generalized linear mixed models
Survival models
Joint survival models
COA data analysis
We have extensive experience with conducting statistical analysis of COA data for post-approval diferentiation in eficacy and safety We have expertise leveraging methods such as:
Linear and generalized linear mixed models
Survival models
Joint survival models
Regulatory COA strategy support
We help Sponsor’s develop a comprehensive COA strategy for clinical trials and offer support with FDA, EMA, PMDA, or NMPA interactions. We have extensive experience liaising with FDA and EMA, and specialize in supporting the development of regulatory documents (e.g., briefing packages, responses to feedback) and attendance of key meetings.
Regulatory COA strategy support
We help Sponsor’s develop a comprehensive COA strategy for clinical trials and offer support with FDA, EMA, PMDA, or NMPA interactions. We have extensive experience liaising with FDA and EMA, and specialize in supporting the development of regulatory documents (e.g., briefing packages, responses to feedback) and attendance of key meetings.
Regulatory COA strategy support
We help Sponsor’s develop a comprehensive COA strategy for clinical trials and offer support with FDA, EMA, PMDA, or NMPA interactions. We have extensive experience liaising with FDA and EMA, and specialize in supporting the development of regulatory documents (e.g., briefing packages, responses to feedback) and attendance of key meetings.
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